The Impact of Predilation Prior to Transcatheter Aortic Valve Implantation with the Self-Expanding ACURATE Neo Device: From the Multicenter Neopro Registry

 

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Objectives: Transcatheter aortic valve replacement (TAVR) has become a first-line therapeutic option in patients with severe, symptomatic aortic stenosis with a high or intermediate surgical risk. The self-expanding ACURATE neo bioprosthesis (Boston Scientific, Marlborough, Massachusetts) is a next-generation THV that provided promising clinical and echocardiographic results. Considering the low radial force of the ACURATE neo THV, preimplantation balloon aortic valve valvuloplasty (pre-BAV) before valve implantation was recommended and almost always performed in early experience with this device. However, omitting predilatation could be appealing to simplify the procedure and reduce the risk of potential balloon aortic valvuloplasty (BAV)-related complications. Aim of this study was to evaluate the use and effects of pre-BAV prior to TAVR with ACURATE neo THV.

Methods: The NEOPRO Registry retrospectively included 1,263 patients who underwent transfemoral TAVR with ACURATE neo at 18 centers between January 2012 and March 2018. Information on pre-BAV was available for 1,262 patients (99.9%). Primary endpoints were pre-discharge moderate-to-severe paravalvular aortic regurgitation [PAR II+], 30-day new permanent pacemaker implantation [PPI], and 30-day all-cause mortality or stroke.

Result: A total of 1,262 patients who underwent transfemoral ACURATE neo implantation with (n = 1,051) or without predilatation (n = 211) were included. A reduction in the rate of pre-BAV was observed during the study period (from 95.7% in the first date quintile to 78.4% in the last date quintile). Patients who underwent pre-BAV had higher degrees of aortic valve (AV) and left ventricular outflow tract (LVOT) calcification. Primary endpoints were similar between pre-BAV and no pre-BAV groups (PAR II+ 5.5 vs. 3.4%, p = 0.214; 30-day PPI 9.0% vs. 8.0%, p = 0.660; 30-day death or stroke 4.9 vs. 4.4%, p = 0.743). The need for postdilatation and other procedural outcomes were comparable between groups. Predilatation did not have a significant impact on primary endpoints across AV and LVOT calcification subgroups and was not independently associated with primary endpoints.

Conclusion: Transfemoral ACURATE neo implantation without predilatation appears to be feasible and safe, especially in patients with mild AV calcification and none-to-mild LVOT calcification. This simplified, direct TAVR approach is increasingly performed across high-volume TAVR centers and is associated with similar clinical outcomes compared with ACURATE neo implantation with predilatation.

Publication History

Article published online:
19 February 2021

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